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Completed

NCT Number: NCT06379490

Ultrasound-guided Infraclavicular Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures

To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations but at the same volume. In addition to motor and sensory blockade during repositioning, feasibility will also be assessed by other patient-related and block-related factors, as well as by factors related to the repositioning and plastering procedure.

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Key information

Conditions

Distal Radius Fractures Arm Injuries Closed Reduction of Fracture and Application of Plaster Cast Colles' Fracture Fracture Dislocation Fractures, Bone Joint Diseases Joint Dislocations Lidocaine Musculoskeletal Diseases Radius Fractures Ropivacaine Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who have given written informed consent to participate in the study after having understood it, as well as:

  • Having a distal radius fracture requiring closed reduction

Exclusion criteria

Patients who meet one or more of the following criteria will be excluded from participating in the study:

  • BMI > 40 kg/m2
  • Weight < 50 kg
  • Age < 18 years
  • American Society of Anesthesiologists (ASA) physical status classification system grade >3
  • Allergy to experimental drugs
  • Patients who cannot cooperate with the examinations or treatment
  • Patients who do not understand or speak Danish
  • Patients with peripheral or central neurological disease or nerve damage with neurological effect on the upper extremity, where closed reduction is required

Treatment and study plan

Ropivacaine 0.2% Injectable Solution

Drug

30 ml of Ropivacaine 0.2% = 60 mg ropivacaine

Other names: Ropivacaine 2 mg/ml

Lidocaine Epinephrine

Drug

30 ml of Lidocaine 1% with 5 μg/ml epinephrine = 300 mg lidocaine + 150 μg epinephrine

Other names: Lidocaine 10 mg/ml

Ropivacaine 0.5% Injectable Solution

Drug

30 mL of Ropivacaine 0.5% = 150 mg Ropivacaine

Other names: Ropivacaine 5 mg/ml

Primary outcomes

  1. Block success

    Time frame: 45 minutes after block performance

    The incidence of successful blockade 45 minutes after block performance.

    The following 4 nerves will be tested: radial, musculocutaneous, ulnar and median nerves.

    Sensory blockade assessment:

    • A 3-point scale is used for cold sensation assessment: 1 point = normal sensation of cold, 2 points = reduced sensation of cold and 3 points = no cold sensation.
    • A complete sensory blockade is defined as all four nerves obtaining 3 points (no cold sensation).

    Motor blockade assessment:

    • Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, the movement against resistance is possible, 2 points = a slight difference, the movement against slight resistance is possible, 1 point = movement is significantly compromised, 0 points = paralysis.
    • A complete motor blockade is defined as all four nerves obtaining: 1 point or 0 points.

    Successful blockade:

    • Complete sensory and motor blockade 45 minutes after block performance.

Other outcomes

  1. Degree of sensory and motor blockade

    Time frame: 30 to 45 minutes after block performance

    Degree of sensory and motor blockade 30 and 45 minutes after block performance.

    Sensory blockade assessment:

    • A 3-point scale is used for cold sensation assessment: 1 point = normal sensation of cold, 2 points = reduced sensation of cold and 3 points = no cold sensation.
    • A complete sensory blockade is defined as all four nerves obtaining 3 points (no cold sensation).

    Motor blockade assessment:

    • Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, movement against resistance is possible, 2 points = a slight difference, movement against slight resistance is possible, 1 point = movement is significantly compromised, 0 point = paralysis.
    • A complete motor blockade is defined as all four nerves obtaining: 1 point or 0 points.

  2. Total duration of sensory blockade

    Time frame: 24 hours after completed block performance

    From the completion of the LIC block until the ending of the sensory blockade.

    Duration in hours:minutes.

  3. Total duration of motor blockade

    Time frame: 24 hours after completed block performance

    From the completion of the LIC block until the ending of motor blockade.

    Duration in hours:minutes.

  4. Pain intensity before block performance

    Time frame: Up to 45 minutes after inclusion interview

    Pain intensity measured before block performance with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable))

  5. Time to pain relief/lowest pain intensity

    Time frame: Up to 45 minutes after block performance

    Time to pain relief/lowest pain intensity after block performance and before performing the closed reduction

    Duration in hours:minutes

  6. Pain intensity during closed reduction

    Time frame: Duration of closed reduction (approx. 5 to 10 minutes)

    Pain intensity measured during closed reduction with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable))

  7. Pain intensity during cast application

    Time frame: Duration of cast application (approx. 5 to 10 minutes)

    Pain intensity measured during cast application with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable))

  8. Time to pain breakthrough after the blockade has ended

    Time frame: Up to 24 hours after block performance

    Time after block performance until pain breakthrough defined as NRS>3 (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable))

    Duration in hours:minutes

  9. Maximum pain intensity after the blockade has ended

    Time frame: Up to 24 hours after block performance

    Pain intensity measured after the blockade has ended with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable))

  10. Duration of maximum pain intensity after the blockade has ended

    Time frame: Up to 24 hours after block performance

    Time period of maximum pain intensity after the blockade has ended

    Duration in hours:minutes

  11. Amount of strong painkillers consumed by patients within 24 hours after closed reduction

    Time frame: 24 hours after completed block performance

    Amount of strong painkillers consumed by patients within 24 hours after closed reduction will be measured in 24-hour morphine equivalents (milligrams).

  12. Grading of closed reduction difficulty

    Time frame: Duration of closed reduction (approx. 5 to 10 minutes)

    Grading of closed reduction difficulty measured with a numeric rating scale (NRS 0 - 10 (0 = no difficulty; 10 = very difficult))

  13. Quality of closed reduction evaluated by X-ray imaging

    Time frame: 24 hours and 30 days after block performance

    Quality of closed reduction evaluated by X-ray imaging using the following radiological criteria:

    • More than 10 degrees of dorsal angulation of the articular surface of the radial in a side view as compared to perpendicular to the longitudinal axis of the radial
    • Ulnar variance of more than 2 mm
    • Articular step-off of more than 2 mm
    • Incongruity of the distal radioulnar joint
    • Loss of substance/comminuted fracture of the dorsal cortex

  14. Attempts used for closed reduction

    Time frame: Up to 4 hours after block application

    Number of attempts used for closed reduction. One attempt is defined as closed reduction before X-ray control imaging.

  15. Grading of casting difficulty

    Time frame: Duration of cast application (approx. 5 to 10 minutes

    Grading of casting difficulty measured with a numeric rating scale (NRS 0 - 10 (0 = no difficulty; 10 = very difficult))

  16. The patient's experience of the treatment

    Time frame: Up to 24 hours after block performance

    The patient's experience of the treatment using a numeric rating scale (NRS 0 - 10 (0 = very dissatisfied; 10 = very satisfied))

  17. Occurence of adverse events (AE) and serious adverse events (SAE)

    Time frame: 24 hours and 30 days after block performance

    Adverse events are defined as any harmful or unwanted events, signs, or symptoms that occur during participation in the study period.

    Serious adverse events are defined as events resulting in death, a life-threatening condition, permanent disability, hospital admission, or prolonged hospital admission.

    Based on phone interviews and medical records 24 hours and 30 days after the procedure.

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Official study title

Effect of Ultrasound-guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures - A Randomized Controlled Non-inferiority Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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